Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

NCT ID: NCT06991127

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-23
• Study Completion Date: 2026-06-01

Brief Summary

The purpose of this pre-market, multicentric cross-sectional study is to create a mesopic Normative Database for a new version of the MAIA device. Moreover, the study aims to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects, who will undergo microperimetric examinations with the MAIA device during one single visit.

Conditions

Healthy Eyes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Main Arm

\*) one microperimetric examination with MAIA

Group Type: EXPERIMENTAL

MAIA

Intervention Type: DEVICE

MAIA is an automatic microperimeter with fundus imaging capabilities that measures retinal sensitivity, fixation stability and locus of fixation, and allows the acquisition of confocal images of the retina, thanks to its confocal scanning imaging system which uses infrared and visible light.

Interventions

MAIA

MAIA is an automatic microperimeter with fundus imaging capabilities that measures retinal sensitivity, fixation stability and locus of fixation, and allows the acquisition of confocal images of the retina, thanks to its confocal scanning imaging system which uses infrared and visible light.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age: ≥18 years old;
• Best Corrected Visual Acuity (BCVA): ≥ 0.8 Decimal (≥ 20/25 ft, ≤ +0.1 logMAR) at least in the study eye;
• Equivalent spherical refraction between the range ≥ -6D and ≤ +6D; astigmatism within 2D (≤ 2D) at least in the study eye;
• Intraocular Pressure (IOP) ≤ 21 mmHg in both eyes (Goldmann applanation tonometer);
• Clinically normal appearance of the optic nerve head according to clinical judgement (no evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning) in both eyes. This is examined with Spectralis or Solix OCT;
• Clinically normal appearance of the macula according to clinical judgement, in both eyes. This is examined with Spectralis or Solix OCT;
• No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery or peripheral laser retinopexy performed at least 6 months before enrollment) in both eyes;
• Absence of pathologies that can affect visual field in both eyes;
• No use of drugs interfering with the correct execution of perimetry.

Exclusion Criteria

• Glaucoma or glaucoma suspect diagnosis in either eye;
• Presence or history of ocular hypertension (IOP ≥ 22 mmHg) in either eye;
• Presence or history of disc hemorrhage in either eye;
• Presence of amblyopia in either eye;
• Nystagmus or poor fixation in either eye;
• Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment in both eyes;
• Any active infection of anterior or posterior segments in the study eye;
• Subjects with significant ocular media opacities preventing acquisition of acceptable infrared (IR) fundus image quality in the study eye;
• Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease in either eye;
• Use of any drug that can interfere with the correct execution of MP or that would produce visual field loss;
• Unable to tolerate ophthalmic imaging;
• Claustrophobia;
• Inability to provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centervue SpA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maximilian Pfau, PD Dr. med.

Role: STUDY_CHAIR

Universitätsspital Basel, Augenklinik

Locations

The Eye Care Institute

Fort Lauderdale, Florida, United States

Site Status: NOT_YET_RECRUITING

UWA Eye Health Centre of Western Australia

Perth, Western Australia, Australia

Site Status: NOT_YET_RECRUITING

Universitätsspital Basel, Augenklinik

Basel, Switzerland, Switzerland

Site Status: RECRUITING

Countries

United States; Australia; Switzerland

Central Contacts

Maximilian Pfau, PD Dr. med.

Role: CONTACT

maximilian.pfau@usb.ch

78 215 42 67 ext. +41

Facility Contacts

Julie Rodman, Professor

Role: primary

rjulie@nova.edu

(954) 262-4274

Allison McKendrick, Professor

Role: primary

allison.mckendrick@uwa.edu.au

8 64887409 ext. +61

Kristina Pfau, PD Dr. med.

Role: primary

kristina.pfau@usb.ch

78 480 38 37 ext. +41

Other Identifiers

MAIA_003_MNDB

Identifier Type: -

Identifier Source: org_study_id